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Post Market Surveillance Manager

Medtronic
Irvine, CA 92604
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Post Market Surveillance Manager

Location:

Irvine, California, United States

Requisition #:

20000CHC

Post Date:

Aug 17, 2020


**Position Description:**

**Post Market Surveillance Manager, Covidien LP (a Medtronic company),Irvine, CA. The Post Market Surveillance Manager located at the Irvine, CAlocation has responsibility and authority related to complaint handling,complaint analysis and adverse experience reporting activities forNeurovascular products and systems. Collaborate to improve and adhere toRestorative Therapies Group Customer Quality standards. Have overallresponsibility to ensure complaint handling and vigilance are optimized andexecuted appropriately to meet the changing needs of the global regulatoryrequirements. Responsible for all complaint analysis activities, Medical DeviceReporting (MDR) and complaint handling to include FDA adverse event reportingrequirements. Utilize problem solving tool using Define, Measure, Analyze,Improve and Control (DMAIC) methodology. Navigate the complexities of variousMedical Device Regulations to include FDA QSR 21 CFR part 820, 803 806,EU Medical Device Regulations, ISO-13485, ISO-14971 and ISO 9001. Utilize LeanManufacturing and Six Sigma methodologies. Coordinate CAPA (Corrective andPreventive Action) planning and implementation. Responsible for various RiskDeliverables including Use, Design and Process Failure Mode Effects Analysis(U/D/PFMEA) and Product Hazard Analysis. Responsible for Complaint and ProductFailure Investigations and pre and post market root cause analysis along withresponses to regulatory inquiries.**


**Basic Qualifications:**


**Masters degree in Nursing, Biology or BiomedicalEngineering and 3 years of experience in Medical Device Reporting compliance.Must possess a minimum of 3 years of experience with each of the following:Complaint analysis activities, Medical Device Reporting (MDR) and complainthandling to include FDA adverse event reporting requirements; DMAICmethodology; FDA QSR 21 CFR part 820, 803 806, ISO-13485, ISO-14971 andISO 9001; Lean manufacturing and Six Sigma methodologies; CAPA (Corrective andPreventive Action) planning and implementation; Use, Design and Process FailureMode Effects Analysis (U/D/PFMEA) and Product Hazard Analysis; and Complaintand Product Failure Investigations and pre and post market root cause analysis,and responses to regulatory inquiries.**
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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Posted: 2020-08-20 Expires: 2020-10-26
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Post Market Surveillance Manager

Medtronic
Irvine, CA 92604

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